Shoulder Impingement SyndromeNCT02870257
Effects of Overload Progressive in the Treatment of Shoulder
A study testing Strengthening protocol with progressive load and Strengthening protocol without progressive load in people with Shoulder Impingement Syndrome, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Strengthening protocol with progressive load and Strengthening protocol without progressive load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis
- shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS
- at least 130° shoulder active elevation
- 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy
- positive dynamic scapular dyskinesis in clinical observation
Who cannot join
- Referred pain from vertebral spine
- previous shoulder, elbow or neck surgery
- complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)
- neoplastic or neurological disorders
- previous fracture or dislocation injury (shoulder, humerus, clavicle)
- adhesive capsulitis signs
Show all 10Show fewer
- inflammatory diseases
- specific treatment for the shoulder in the previous four months (injection, physiotherapy)
- using drugs in the previous week
- inability to understand portuguese language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial
Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 sessions).
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Strengthening protocol with progressive load, Strengthening protocol without progressive load
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening protocol with progressive loadOther
Strengthening protocol for scapular and shoulder muscles
Strengthening protocol without progressive loadOther
Strengthening protocol for scapular and shoulder muscles
| Study group | Role | What they receive |
|---|---|---|
| Progressive overload strengthening group | Experimental | Strengthening protocol with progressive load
Strengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions) Receives: Other: Strengthening protocol with progressive load |
| Strengthening group | Active comparator | Strengthening protocol without progressive load
Strengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions) Receives: Other: Strengthening protocol without progressive load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric pain rating scale (0-10)
Measured: baseline, 10 weeks, 3 months and 6 months
Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)
Measured: baseline, 10 weeks, 3 months and 6 months
Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)
Measured: baseline, 10 weeks, 3 months and 6 months
Secondary outcomes (5)
Disabilities
DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire (0-100)
Measured: Change from baseline at 10 weeks
Quality of life
WORC (The Western Ontario Rotator Cuff Index) Questionnaire (0-100)
Measured: Change from baseline at 10 weeks
Muscle Strength
Shoulder internal rotation, external rotation, adduction and abduction muscles measured by handheld dynamometer
Measured: Change from baseline at 10 weeks
Scapular kinematic
3D data of scapula at 30, 60, 90 and 120° of shoulder abduction
Measured: Change from baseline at 10 weeks
Global impression of recovery
GPE (global perceived effect) scale (-5 to +5)
Measured: Change from baseline at 10 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Serra Bley, University of Nove de Julho
- Investigators
- André S Bley, Msd, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870257
- Sponsor's protocol ID
- 1.487.198
- Status last verified
- Oct 2017
- First submitted
- 4 Aug 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02870257
- Acronym / sponsor ID
- 1.487.198
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 sessions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive overload strengthening group | Experimental | Other: Strengthening protocol with progressive loadStrengthening protocol with progressive load Strengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions) |
| Strengthening group | Active comparator | Other: Strengthening protocol without progressive loadStrengthening protocol without progressive load Strengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis
- shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS
- at least 130° shoulder active elevation
- 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy
- positive dynamic scapular dyskinesis in clinical observation
Key exclusion criteria (10 listed)
- Referred pain from vertebral spine
- previous shoulder, elbow or neck surgery
- complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)
- neoplastic or neurological disorders
- previous fracture or dislocation injury (shoulder, humerus, clavicle)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening protocol with progressive loadStrengthening protocol for scapular and shoulder muscles | Other | Progressive overload strengthening group |
| Strengthening protocol without progressive loadStrengthening protocol for scapular and shoulder muscles | Other | Strengthening group |
Primary outcome
Change in Numeric pain rating scale (0-10)
Time frame: baseline, 10 weeks, 3 months and 6 months
Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)
Time frame: baseline, 10 weeks, 3 months and 6 months
Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)
Time frame: baseline, 10 weeks, 3 months and 6 months
5 secondary outcomes
Disabilities
Time frame: Change from baseline at 10 weeks
Quality of life
Time frame: Change from baseline at 10 weeks
Muscle Strength
Time frame: Change from baseline at 10 weeks
Scapular kinematic
Time frame: Change from baseline at 10 weeks
Global impression of recovery
Time frame: Change from baseline at 10 weeks, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André S Bley, Msd principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening protocol with progressive load and Strengthening protocol without progressive load in people with Shoulder Impingement Syndrome, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric pain rating scale (0-10) (time frame: baseline, 10 weeks, 3 months and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.